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Last Updated: May 24, 2022

KYPROLIS Drug Patent Profile


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When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and twenty-three patent family members in forty-one countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.

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Summary for KYPROLIS
Drug patent expirations by year for KYPROLIS
Drug Prices for KYPROLIS

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
PETHEMA FoundationPhase 1/Phase 2

See all KYPROLIS clinical trials

Paragraph IV (Patent) Challenges for KYPROLIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KYPROLIS For Injection carfilzomib 10 mg/vial 202714 1 2018-11-28
KYPROLIS For Injection carfilzomib 30 mg/vial 202714 1 2017-10-05
KYPROLIS For Injection carfilzomib 60 mg/vial 202714 9 2016-07-20

US Patents and Regulatory Information for KYPROLIS

KYPROLIS is protected by twenty US patents and one FDA Regulatory Exclusivity.

Patents protecting KYPROLIS

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Composition for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Compounds for enzyme inhibition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination therapy with peptide epoxyketones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

FDA Regulatory Exclusivity protecting KYPROLIS

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY IN COMBINATION WITH DARATUMUMAB AND DEXAMETHASONE
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for KYPROLIS

When does loss-of-exclusivity occur for KYPROLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05243140
Estimated Expiration: See Plans and Pricing

Patent: 05243168
Estimated Expiration: See Plans and Pricing

Patent: 05313975
Estimated Expiration: See Plans and Pricing

Austria

Patent: 9109
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510802
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65407
Estimated Expiration: See Plans and Pricing

Patent: 66839
Estimated Expiration: See Plans and Pricing

Patent: 89921
Estimated Expiration: See Plans and Pricing

China

Patent: 1014612
Estimated Expiration: See Plans and Pricing

Patent: 1180071
Estimated Expiration: See Plans and Pricing

Patent: 2847136
Estimated Expiration: See Plans and Pricing

Patent: 2875642
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11489
Estimated Expiration: See Plans and Pricing

Patent: 14025
Estimated Expiration: See Plans and Pricing

Patent: 15605
Estimated Expiration: See Plans and Pricing

Patent: 17507
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 19353
Estimated Expiration: See Plans and Pricing

Patent: 30981
Estimated Expiration: See Plans and Pricing

Patent: 60835
Estimated Expiration: See Plans and Pricing

Patent: 61236
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 56079
Estimated Expiration: See Plans and Pricing

Patent: 58921
Estimated Expiration: See Plans and Pricing

Patent: 19353
Estimated Expiration: See Plans and Pricing

Patent: 30981
Estimated Expiration: See Plans and Pricing

Patent: 60835
Estimated Expiration: See Plans and Pricing

Patent: 61236
Estimated Expiration: See Plans and Pricing

Patent: 64834
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005026556
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 07948
Estimated Expiration: See Plans and Pricing

Patent: 27618
Estimated Expiration: See Plans and Pricing

Patent: 51966
Estimated Expiration: See Plans and Pricing

Patent: 52047
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27850
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9020
Estimated Expiration: See Plans and Pricing

Patent: 9151
Estimated Expiration: See Plans and Pricing

Patent: 3607
Estimated Expiration: See Plans and Pricing

Patent: 4776
Estimated Expiration: See Plans and Pricing

Patent: 3546
Estimated Expiration: See Plans and Pricing

Patent: 6171
Estimated Expiration: See Plans and Pricing

Japan

Patent: 90155
Estimated Expiration: See Plans and Pricing

Patent: 08509
Estimated Expiration: See Plans and Pricing

Patent: 07537265
Estimated Expiration: See Plans and Pricing

Patent: 07538081
Estimated Expiration: See Plans and Pricing

Patent: 08522981
Estimated Expiration: See Plans and Pricing

Patent: 12121895
Estimated Expiration: See Plans and Pricing

Patent: 14141456
Estimated Expiration: See Plans and Pricing

Poland

Patent: 19353
Estimated Expiration: See Plans and Pricing

Patent: 30981
Estimated Expiration: See Plans and Pricing

Patent: 60835
Estimated Expiration: See Plans and Pricing

Patent: 61236
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 19353
Estimated Expiration: See Plans and Pricing

Patent: 30981
Estimated Expiration: See Plans and Pricing

Patent: 60835
Estimated Expiration: See Plans and Pricing

Patent: 61236
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 84585
Estimated Expiration: See Plans and Pricing

Patent: 06143664
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5963
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 19353
Estimated Expiration: See Plans and Pricing

Patent: 30981
Estimated Expiration: See Plans and Pricing

Patent: 60835
Estimated Expiration: See Plans and Pricing

Patent: 61236
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1299821
Estimated Expiration: See Plans and Pricing

Patent: 070086924
Estimated Expiration: See Plans and Pricing

Spain

Patent: 60811
Estimated Expiration: See Plans and Pricing

Patent: 08216
Estimated Expiration: See Plans and Pricing

Patent: 10840
Estimated Expiration: See Plans and Pricing

Patent: 49763
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYPROLIS around the world.

Country Patent Number Title Estimated Expiration
Portugal 3101026 See Plans and Pricing
Singapore 155187 COMPOUNDS FOR PROTEASOME ENZYME INHIBITION See Plans and Pricing
Japan 2017052770 ペプチドエポキシケトンを用いた併用療法 (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONE) See Plans and Pricing
South Korea 20070086924 COMPOSITION FOR PROTEASOME INHIBITION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYPROLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 PA2016010,C1781688 Lithuania See Plans and Pricing PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 C20160008 00189 Estonia See Plans and Pricing PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
1781688 CR 2016 00014 Denmark See Plans and Pricing PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 12/2016 Austria See Plans and Pricing PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Moodys
Baxter
Mallinckrodt
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.